pijnbestrijding pain postoperative pain
Conditions
Interventions
All subjects will be tested 4 times on 4 separate occasions at least 1 week
apart. On each visit they will receive one of the following doses: Oliceridine
0.5 mg IV, Oliceridine 2.0 mg IV, Morphine
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Absence of any significant medical, neurologic, or psychiatric illness as determined by the investigators. - Age 55 yr or older; - Body mass index (BMI) of 19 - 35 kg/m2. The BMI range is relatively large to obtain a representative sample of individuals in the population. - Willingness and competence to sign written informed consent. - Screening cold pressor test hand removal latencies of > 20 and
Exclusion criteria
Exclusion criteria: 1. Clinically significant medical, surgical, psychiatric or substance abuse condition or history of such condition that would confound the interpretation of data in the study. 2. Clinically significant, immune mediated hypersensitivity reaction or intolerance to opioids. 3. Exposure to opioids or anesthesia within 30 days before the first treatment period of the study. 4. Caffeine within 24 hours before the first treatment period of the study. 5. Positive urine drug screen or alcohol breathalyzer test at the screening visit or positive urine dipstick for substances of abuse or alcohol breath test at each visit. 6. Participation in a previous oliceridine clinical study. 7. Participation in another interventional clinical study within 30 days before the first treatment period of the study. 8. Weight 2 × upper limit of normal [ULN] or elevated hepatic transaminases (aspartate aminotransferase [AST] > 1.5 × ULN OR alanine aminotransferase [ALT] > 1.5 × ULN). 12. Clinically significant abnormality on electrocardiogram, including a QT interval corrected for heart rate (QTcF interval) of > 450 milliseconds, at the screening visit. 13. Clinically significant, immune mediated hypersensitivity reaction or intolerance to 5-HT3 inhibitors. 14. Unsuitable screening HCVR test results (e.g., ability to tolerate the mask, breathe in a regular fashion, increase ventilation in response to increases in inhaled CO2), as judged by the investigator 15. A high risk of obstructive sleep apnea as determined by the STOP-BANG questionnaire (score greater than 4); 16. Alcohol intake of more than 4 units/day or more than 28 units/week; 17. The short version of the Mini Mental State Examination with a score less than 8. The latter exclusion criterion was to prevent that subjects with some form of cognitive impairment participated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypercapnic ventilatory response; Pain relief and plasma concentrations oliceridine and morphine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea, vomiting, sedation, dizziness, lightheadedness, drug likability. | — |
Countries
Netherlands
Outcome results
None listed